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Multi-center clinical trials of Sanjie analgesic capsule in treating endometriosis

A Randomized, double-blind, placebo-controlled clinical study to evaluate of Sanjie analgesic capsule in treating endometriosis pain

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003283
Enrollment
Unknown
Registered
2013-06-04
Start date
2013-07-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometriosis

Interventions

experimental group:oral Sanjie analgesic capsules
control group:oral placebo

Sponsors

Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Endometriosis patients who were diagnosed by laparoscopic within 5 years, complaining of the symptoms of dysmenorrhea; With VAS score of 4 or above; Endometriosis patients with adenomyosis were included. 2. Female, 18-45 years old; 3. Regular menstrual period, menstrual cycle for 28-30 days; 4. No pregnancy planning during taking drugs, tools for contraception; 5. The patient who has signed the ICF and conditional follow-up.

Exclusion criteria

Exclusion criteria: 1. Genital cancer or other malignant tumor; 2. Adnexal masses=5cm; 3. Uterine myoma=3cm; 4. Suffering from cardiovascular, hepatic, renal or hematopoietic system disease or mental illness. 5. Receiving hormone therapy within 3 months before enrolled; 6. Receiving surgical treatment for endometriosis within 3 months before enrolled; 7. Intended to get pregnant in last 3 months or in the stage of pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Dysmenorrhe;

Secondary

MeasureTime frame
Symptom (CPP Dyspareunia Defecate-pain Anal-bulge);Signs(Pelvic-tenderness Tubercle);Menstrual cycle and quantity;CA125;the size of uterus and endometriosis cyst;Concentration of FSH, LH, E2, PRL, P, T;

Countries

China

Contacts

Public ContactJinghe Lang
langjh@hotmail.com+86 13693328258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026